FDA approves a BLA from Sanofis Bioverativ Therapeutics unit for Altuviiio (efanesoctocog alfa), a recombinant DNA-derived, factor VIII concentrate in...
A JAMA study that looked at ivermectin as a therapy for treating adult outpatients with mild to moderate Covid-19 finds that the drug does not reduce ...
FDA adds a new case study to its Examples of Medical Device Misconnections Web page.
FDA posts a sources sought information request that seeks potential contractors who may be able to develop and implement a medical device active surve...
FDA says it is evaluating reports of exposure to airborne chemicals that may be associated with the use of neonatal incubators.
Four Democrat senators and representatives say the U.S. Patent and Trademark Office should weigh a new Merck patent request for a subcutaneous formula...
FDA releases the form FDA-483 issued following an inspection at the Ahmedabad, India-based Amneal Pharmaceuticals Private Limited parenteral manufactu...
CBER director Peter Marks discusses four lessons learned from the rapid development of Covid-19 vaccines and the implications for the future.
